Sunday, October 7, 2012

Compounding Pharmacies & Drug Shortage: the case of Fungal Meningitis

Epidural steroid injections have been an option in the treatment of pain due to spinal disc herniation for many years, and their safety record has been acceptable until now! As we hear in the media, contaminated steroid preparations that were purchased from a non-accredited compounding pharmacy have led to the death of 7 people and the serious illness of at least 47 individuals who were afflicted with fungal meningitis. Many more might show-up over the next days or weeks. By far, this is the worst trend of complications and bad outcomes related to the treatment of epidural steroid injections for painful spinal conditions, which in my opinion will hold back this form of therapy for many years to come, even if the root cause of this tragic development is eradicated.

Our medical history is a living proof of this: a case in point is the landmark Woolley and Roe case that occurred in Britain in 1947. Two patients who received spinal anesthesia on the same day in the same hospital who became permanently paralyzed because of contaminated ampules. Their tragic loss led to the "death" of spinal anesthesia for many years afterwards, particularly in Britain. It took a long while for the practice of spinal anesthesia to recover afterwards, particularly with modern sterilization techniques, better drugs and needles, and improved understanding of the science.

Below is an extract from an article in the Guardian regarding this story (full article here):

An outbreak of meningitis linked to contaminated steroid shots prepared by a Massachusetts pharmacy has now resulted in seven deaths, officials said Saturday as they confirmed that the illness had spread to more states. 
The total number of cases of the rare form of fungal meningitis is now 64, with Minnesota and Ohio added to the list of states affected. 
Since the outbreak was traced to products sent out by an unaccredited pharmaceutical compounding company with a history of health violations, medical clinics across the eastern USA have been making contact with patients given the injection. 
In the past 24 hours, Centers for Disease Control and Prevention (CDC) has added two people to the number of fatalities. The total number of cases has jumped by 17 from Friday's figure of 47. 
The updated figures comes amid growing concern over why clinics from as far away as Florida and Tennessee chose to buy in bulk from a pharmacy that had not applied for accreditation form a professional body and had a checkered health and safety record. 
The outbreak has been traced to the New England Compounding Center, which from premises in Framingham, Massachusetts sent out as many as 17,000 doses of contaminated steroid injections. 
Investigators from the Food and Drug Administration (FDA) who were sent to the company found a fungal contaminate in a sealed vial of the steroid methylprednisolone acetate. They also found a "foreign material" in another, opened container. Tests are being conducted to determine if the contaminants match the one that has led to recent cases of meningitis....


Bilo said...

As of today 137 cases and 12 deaths!

Bilo said...

170 cases and 14 deaths as of today!

Bilo said...

15 deaths as of today!

Bilo said...

Below is a summary of current (as of Oct 23, 2012) investigative facts as reported by the CDC or FDA:
• The FDA’s concern over steroid, methylprednisolone acetate, being contaminated with exserohilum rostratum (a soil fungus) has extended to other drugs made at the New England Compounding Center (NECC.)
• The fungus has been found in sealed steroid vials. Currently, it is unclear how the fungus got into the vials.
• The CDC has indentified 294 cases of fungal meningitis and 3 cases of joint infections. The death toll is 23. The outbreak spans 16 states-: Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.
• As many as 14,000 patients are thought to have received injections of the potentially contaminated steroid.
• The longest duration from the time of injection to the onset of symptoms is 42 days but the CDC is advising to be vigilant “for months.”
• The FDA has provided state health departments with a list of more than 131,000 shipping invoices for drug products that were produced at the NECC facility. The state health departments are using the invoices to identify and alert healthcare facilities that purchased pharmaceuticals from the questionable compounding center. The state health departments are making recommendations on how the healthcare facilities should manage the patient situation. The recommendations vary from state to state.

Bilo said...

39 deaths as of today!